Power-Based Multicomponent Training, Pelvic Floor Muscle Activation Instructions, and Psychoeducation for Urinary Incontinence, Balance and Fear of Falling in Older Women (FIRE-WOMEN): Study Protocol for a Randomized Controlled Trial.

Background/

Objectives

Urinary incontinence (UI) and impaired balance are common geriatric syndromes that negatively affect health and quality of life in older women. However, the combined effects of power-based multicomponent training (PMT), pelvic floor muscle (PFM) activation instructions, and psychoeducational (PSY) support remain unclear. This study aims to evaluate the effects of a PMT, alone or progressively combined with PFM activation instructions and PSY support, on PFM function, UI symptoms, balance, fear of falling, and physical function in community-dwelling older women.

Methods

This study describes the protocol for an 18-week, four-arm additive, parallel-group, assessor- and analyst-blinded randomized controlled trial with a 6-month follow-up. A total of 120 women aged 60-80 years with UI will be randomly assigned to four groups: (1) PMT only (EX), (2) PMT plus verbal PFM activation instructions (EXVERB), (3) PMT combined with PFM activation instructions and psychoeducational sessions (EXVERBPSY), or (4) a control group receiving educational sessions on geriatric syndrome prevention. Sessions will be conducted twice weekly for 18 weeks. The single primary endpoint is maximal PFM strength assessed by the manometric perineometry. Pre-specified secondary outcomes include additional PFM function measures, upper- and lower-limb (LL) strength and power, balance performance, fear of falling, quality of life, psychological well-being, and anthropometric variables. Assessments will be conducted at baseline, post-intervention, and 6-month follow-up. The trial is registered at ClinicalTrials.gov (NCT06839040). Expected results: This trial is expected to provide evidence on the effectiveness of a multidisciplinary intervention combining exercise, PFM activation strategies, and PSY support for reducing UI severity and improving balance performance and fear of falling in older women.

Conclusions

This protocol describes a four-arm additive randomized controlled trial evaluating a multidisciplinary intervention targeting two highly prevalent and interrelated geriatric syndromes. The study may contribute to the development of more comprehensive exercise-based and PSY interventions for older women and may inform healthcare strategies aimed at promoting healthy ageing and improving the management of UI and fear of falling.